Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle Recalled by Abbott Gmbh & Co. KG Due to Falsely elevated results may be obtained when using...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Gmbh & Co. KG directly.
Affected Products
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
Quantity: 10,153 units
Why Was This Recalled?
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Where Was This Sold?
This product was distributed to 30 states: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MN, MS, MO, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VT, WA, WY
About Abbott Gmbh & Co. KG
Abbott Gmbh & Co. KG has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report